[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06072066":3,"trial-entities:NCT06072066":120,"trial-summary:NCT06072066":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":45,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":89,"locations":92,"central_contacts":111,"overall_officials":117,"references":118,"see_also_links":119},"NCT06072066","i23-04_CL_SkinBarrier_Supp","Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea","The Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea","RECRUITING","2024-12-31","2024-08","2024-08-27","2023-11-22","Integrative Skin Science and Research","INDUSTRY",false,"The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.","Rosacea is a chronic inflammatory condition that widely prevalent in the general population and is associated with both inflammation and dysfunction of the skin barrier. Gut dysfunction has been shown to be present in those with rosacea. This study evaluates how the use of a supplement may improve the gut and skin barrier as well as reduce general inflammation.",[19,20],"Rosacea","Systemic Inflammation",[19,22,23],"L-Histidine","Antioxidants","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},24,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DIETARY_SUPPLEMENT","Skin Barrier Oral Supplement","Supplment powder",[34],[38,42],{"measure":39,"description":40,"timeFrame":41},"Transepidermal water loss (TEWL)","Change in the facial transepidermal water loss (TEWL) using the Vapometer.","8 weeks",{"measure":43,"description":44,"timeFrame":41},"Blood hs-CRP level","Change in blood hs-CRP level through blood spot testing",[46,50,51,54,55,56,57,60,62,65],{"measure":47,"description":48,"timeFrame":49},"Intestinal permeability","Change in intestinal permeability through a urine based test by Genova Diagnostics","4 weeks",{"measure":47,"description":48,"timeFrame":41},{"measure":52,"description":53,"timeFrame":49},"Fecal levels of calprotectin","Change in fecal levels of calprotectin through a stool sample",{"measure":52,"description":53,"timeFrame":41},{"measure":39,"description":40,"timeFrame":49},{"measure":43,"description":44,"timeFrame":49},{"measure":58,"description":59,"timeFrame":49},"Mood Questionnaire","A survey to assess changes in mood",{"measure":58,"description":59,"timeFrame":61},"8 Weeks",{"measure":63,"description":64,"timeFrame":49},"Digestive Questionnaire","A survey to assess digestive health",{"measure":63,"description":64,"timeFrame":41},"ALL","30 Years","70 Years",true,{"inclusion":71,"exclusion":75,"raw_text":88},[72,73,74],"Males and females 30 to 70 years of age","The presence of mild to moderate rosacea (erythematotelangiectatic or papulopustular)","High sensitivity C-reactive protein (hs-CRP) that is greater than or equal to 1.0 mg\u002FL",[76,77,78,79,80,81,82,83,84,85,86,87],"The presence of severe rosacea as noted by the investigator global assessment.","Those who are unwilling to discontinue oral supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.","Discontinuation of oral L-glutamine or L-glutamine containing supplement 1 month prior to enrollment","Those who are unwilling to discontinue topical benzoyl peroxide or retinoids for 2 weeks prior to enrollment.","Those who are unwilling to keep their facial regimen the same throughout the study.","Individuals who have been on an oral antibiotic within the previous one month.","Individuals who are pregnant or breastfeeding.","Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.","Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.","Use of isotretinoin within the three months prior to enrollment.","Individuals on finasteride or dutasteride","Current tobacco smoker, smoker within the past year, or greater than 5 pack-year tobacco smoking history.","Inclusion Criteria:\n\n* Males and females 30 to 70 years of age\n* The presence of mild to moderate rosacea (erythematotelangiectatic or papulopustular)\n* High sensitivity C-reactive protein (hs-CRP) that is greater than or equal to 1.0 mg\u002FL\n\nExclusion Criteria:\n\n* The presence of severe rosacea as noted by the investigator global assessment.\n* Those who are unwilling to discontinue oral supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.\n* Discontinuation of oral L-glutamine or L-glutamine containing supplement 1 month prior to enrollment\n* Those who are unwilling to discontinue topical benzoyl peroxide or retinoids for 2 weeks prior to enrollment.\n* Those who are unwilling to keep their facial regimen the same throughout the study.\n* Individuals who have been on an oral antibiotic within the previous one month.\n* Individuals who are pregnant or breastfeeding.\n* Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.\n* Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.\n* Use of isotretinoin within the three months prior to enrollment.\n* Individuals on finasteride or dutasteride\n* Current tobacco smoker, smoker within the past year, or greater than 5 pack-year tobacco smoking history.",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":108},"Integrative Skin and Research","Sacramento","California","95815","United States",[100,105],{"name":101,"role":102,"phone":103,"email":104},"Raja Sivamani, MD, MS, AP","CONTACT","916-750-2463","research@integrativeskinresearch.com",{"name":106,"role":107},"Raja Sivamani, MD MS AP","PRINCIPAL_INVESTIGATOR",{"lat":109,"lon":110},38.58157,-121.4944,[112,114],{"name":113,"role":102,"phone":103,"email":104},"Caitlin Egli",{"name":115,"role":102,"email":116},"Milred Min","milred@integrativeskinresearch.com",[],[],[],{"nct_id":4,"conditions":121,"biomarkers":122},[19],[],{"nct_id":4,"found":69,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study planning to enroll 24 participants. The phase of the study is not specified.","completed","Oral Supplement for Rosacea and Inflammation","This study is looking at how an oral supplement containing L-Histidine and antioxidants might help people with rosacea. Rosacea is a long-lasting skin condition that can cause redness and bumps, and it's linked to inflammation and problems with the skin's protective barrier. This research aims to see if taking the Skin Barrier Oral Supplement can improve your skin and gut health, and reduce overall inflammation. You might be able to join if you are 30 to 70 years old, have mild to moderate rosacea, and a specific blood marker (hs-CRP) that is 1.0 mg\u002FL or higher. The study will measure changes in your skin's barrier function (Transepidermal water loss, or TEWL) and blood inflammation levels (hs-CRP) after 8 weeks. The current recruitment status is unclear, and they plan to enroll 24 participants.","The primary measurements for this study are taken at 8 weeks.",132,"Not specified in the trial record.","Not stated in the trial record.",[34],"v2"]